Associate Director, Technical Operations - Drug Product
Travere Therapeutics
August 30, 2026
Remote friendly (San Diego Metropolitan Area)
United States
Operations
Position Summary:
The Associate Director, Technical Operations – Drug Product, is responsible for drug product manufacturing, scale up, validation, and commercialization of a small molecule, solid oral drug product. Key CMC contributor from clinical development through commercialization.
Responsibilities:
- Provide technical oversight of production, scale up, process characterization, and PPQ of drug product manufacturing at CDMOs.
- Review/approve manufacturing documents: change notifications, batch records, process development, tech transfer, process characterization, and validation protocols/reports.
- Verify suitability, qualification, and validation of processes at CDMOs and external labs.
- Support GMP quality systems (deviations, investigations, CAPAs, change controls, regulatory submissions, facility inspections).
- Collaborate on CMC development and commercialization with internal/external teams.
- Author/review technical documents and regulatory filings (INDs, IMPDs, NDAs).
- Maintain knowledge of US/EU GMPs and applicable regulatory guidance.
- Ensure CDMO contractual scope meets quality standards and timelines; recommend improvements to leadership.
Education/Experience Requirements:
- Bachelor’s in Chemistry/Pharm Sciences/Biochemistry/Chemical Engineering or related; MS/PhD in related field preferred.
- 8+ years relevant experience in small molecule drug product manufacturing (scale-up, late phase, commercialization).
- Experience with amorphous solid dispersions (spray-dried preferred); solid oral (granulation, capsules/tablets) a plus.
- Expert knowledge of process development, characterization, PPQ, and commercialization for solid oral products.
- Skilled in CMC modules for IND/IMPD/NDA; extensive experience managing global CDMOs and/or third-party labs.
- Knowledge of phase-appropriate cGMP and US/EU/ICH guidelines.
Additional/Preferred Skills:
- Courage, community spirit, patient focus, teamwork; strong communication, collaboration, and attention to detail.
- Project planning/timelines/budgets and risk mitigation; adaptability to change.
- Six Sigma/statistical knowledge plus.
- Travel 10–20%.
- Not 100% remote; ability to work onsite in San Diego.
Benefits:
- Premium health, wellness/employee support, life insurance, disability, retirement with employer match, generous paid time off.
- Target base pay range: $150,000–$195,000.
Application Instructions:
- Travere accepts applications on an ongoing basis until a candidate is selected for the position.
The Associate Director, Technical Operations – Drug Product, is responsible for drug product manufacturing, scale up, validation, and commercialization of a small molecule, solid oral drug product. Key CMC contributor from clinical development through commercialization.
Responsibilities:
- Provide technical oversight of production, scale up, process characterization, and PPQ of drug product manufacturing at CDMOs.
- Review/approve manufacturing documents: change notifications, batch records, process development, tech transfer, process characterization, and validation protocols/reports.
- Verify suitability, qualification, and validation of processes at CDMOs and external labs.
- Support GMP quality systems (deviations, investigations, CAPAs, change controls, regulatory submissions, facility inspections).
- Collaborate on CMC development and commercialization with internal/external teams.
- Author/review technical documents and regulatory filings (INDs, IMPDs, NDAs).
- Maintain knowledge of US/EU GMPs and applicable regulatory guidance.
- Ensure CDMO contractual scope meets quality standards and timelines; recommend improvements to leadership.
Education/Experience Requirements:
- Bachelor’s in Chemistry/Pharm Sciences/Biochemistry/Chemical Engineering or related; MS/PhD in related field preferred.
- 8+ years relevant experience in small molecule drug product manufacturing (scale-up, late phase, commercialization).
- Experience with amorphous solid dispersions (spray-dried preferred); solid oral (granulation, capsules/tablets) a plus.
- Expert knowledge of process development, characterization, PPQ, and commercialization for solid oral products.
- Skilled in CMC modules for IND/IMPD/NDA; extensive experience managing global CDMOs and/or third-party labs.
- Knowledge of phase-appropriate cGMP and US/EU/ICH guidelines.
Additional/Preferred Skills:
- Courage, community spirit, patient focus, teamwork; strong communication, collaboration, and attention to detail.
- Project planning/timelines/budgets and risk mitigation; adaptability to change.
- Six Sigma/statistical knowledge plus.
- Travel 10–20%.
- Not 100% remote; ability to work onsite in San Diego.
Benefits:
- Premium health, wellness/employee support, life insurance, disability, retirement with employer match, generous paid time off.
- Target base pay range: $150,000–$195,000.
Application Instructions:
- Travere accepts applications on an ongoing basis until a candidate is selected for the position.